CLASS II ONGOING Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
BioPlex 2200 REF 12000650 Syph T Pack Syphilis Total & RPR Reagent recalled
Bio-Rad Laboratories is recalling BioPlex 2200 REF 12000650 Syph T Pack Syphilis Total & RPR Reagent, distributed nationwide in the US. The recall was initiated on 8 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0806-2022
- FDA event ID
- 89684
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Feb 2022
- FDA classified
- 16 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Feb 2022 | Recall initiated by company | |
| 16 Mar 2022 | Classified by FDA | +36 days |
| 23 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Where it was distributed
Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Which lots are affected?
Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
Where was it sold?
Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 89684| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL recalled | Bio-Rad Laboratories | Potency & Assay | Nationwide |
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